nilotinib (Rx)

Brand and Other Names:Tasigna
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 150mg
  • 200mg
more...

Chronic Myeloid Leukemia

Newly diagnosed Ph+ CML-CP

  • Indicated for initial treatment of newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML)
  • 300 mg PO q12hr

Resistant or intolerant

  • Indicated for treatment of CP and accelerated phase (AP) Ph+ CML in patients resistant to or intolerant to prior therapy that included imatinib
  • 400 mg PO q12hr

Gastrointestinal Stromal Tumors (Orphan)

Orphan indication sponsor

  • Novartis Pharmaceuticals Corporation; One Health Plaza; East Hanover, NJ 07936-1080

Dosage Modifications

Neutropenia and thrombocytopenia

  • Adults with newly diagnosed Ph+ CP-CML or resistant or intolerant CP and AP Ph+ CML
    • Absolute neutrophil count (ANC) <1 x 10^9/L or platelet <50x 10^9/L: Stop nilotinib and monitor blood counts
    • Within 2 weeks of recovery: Resume original dose if ANC >1 x 10^9/L & platelet >50 x 10^9/L
    • If levels remain low for >2 weeks: Reduce dose to 400 mg qDay

QT Prolongation (QTc >480 msec)

  • Withhold drug and analyze serum potassium and magnesium; if below lower limit of normal, correct with supplements to within normal limits
  • Review concomitant medications for additive effects or interactions that increase nilotinib systemic exposure
  • Resume within 2 weeks at prior dose if QTc returns to <450 msec and to within 20 msec of baseline
  • If QTc is between 450-480 msec after 2 weeks, reduce nilotinib dose to 400 mg qDay
  • Discontinue if QTc returns to >480 msec despite reducing the dose to 400 mg/day
  • Repeat ECG ~7 days after any dose adjustment

Moderate or severe nonhematologic toxicity

  • Resume treatment at 400 mg qDay if previous dose was 300 mg qDay (newly diagnosed Ph+ CML-CP) or 400 mg BID (resistant or intolerant Ph+ CML-CP and CML-AP); discontinue treatment if prior dose was 400 mg qDay
  • If clinically appropriate, consider re-escalate dose to 300 mg qDay (newly diagnosed Ph+ CML-CP) or 400 mg BID (resistant or intolerant Ph+ CML-CP and CML-AP)

Elevated serum lipase or amylase ≥Grade 3

  • Withhold nilotinib, and monitor serum lipase or amylase
  • Resume treatment at 400 mg qDay if serum lipase or amylase returns to ≤Grade 1

Elevated bilirubin or alanine transaminase (ALT)/aspartate transaminase (AST) ≥Grade 3

  • Withhold nilotinib, monitor bilirubin
  • Resume treatment at 400 mg qDay if serum bilirubin returns to ≤Grade 1

Hepatic impairment

  • Newly diagnosed Ph+ CML (chronic phase at 300 mg BID)
    • Mild, moderate, or severe hepatic (Child-Pugh A to C): Start initial dose at 200 mg BID; if tolerated, may increase to 300 mg BID
  • Resistant or intolerant Ph+ CML (chronic phase or accelerated phase at 400 mg BID)
    • Mild or moderate (Child-Pugh A to B): Start initial dose at 300 mg BID; if tolerated, may increase to 400 mg BID
    • Severe (Child-Pugh C): Start initial dose at 200 mg BID; if tolerated, may increase to 300 mg BID, and then 400 mg BID

Renal impairment

  • Clinical studies have not been performed in patients with impaired renal function
  • Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment

Consider discontinuation of treatment after a sustained molecular response

  • Monitor BCR-ABL transcript levels and complete blood count (CBC) with differential in patients who have discontinued therapy monthly for 1 year, then q6Weeks for the second year, and q12Weeks thereafter
  • Newly diagnosed Ph+ CML-CP
    • Treatment with nilotinib for at least 3 years
    • Maintain a molecular response of at least MR4.0 (corresponding to = BCR-ABL/ABL ≤0.01% IS) for 1 year prior to discontinuation of therapy
    • Achieved an MR4.5 for the last assessment taken immediately prior to discontinuation of therapy
    • Been confirmed to express the typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2)
    • No history of accelerated phase or blast crisis
    • No history of prior attempts of treatment-free remission discontinuation that resulted in relapse
  • Patients with Ph+ CML-CP that are resistant or intolerant to treatment with imatinib
    • Treatment with nilotinib for at least 3 years
    • Previously treated with imatinib only prior to treatment with nilotinib
    • Achieved a molecular response of MR.4.5 (corresponding to = BCR-ABL/ABL ≤0.0032% IS)
    • Sustained an MR4.5 for a minimum of one year immediately prior to discontinuation of therapy
    • Been confirmed to express the typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2)
    • No history of accelerated phase or blast crisis
    • No history of prior attempts of treatment-free remission discontinuation that resulted in relapse

Reinitiating treatment if molecular response lost after discontinuing therapy

  • Newly diagnosed patients
    • Patients who lose MMR must reinitiate treatment within 4 weeks at the dose level prior to discontinuing treatment
    • Monitor BCR-ABL transcript levels monthly until major molecular response is re-established and q12Weeks thereafter
  • Resistant or intolerant Ph+ CML (chronic phase or accelerated phase)
    • Patients resistant or intolerant to prior treatment that included imatinib with confirmed loss of MR4.0 (2 consecutive measures separated by at least 4 weeks showing loss of MR4.0) or loss of MMR must reinitiate treatment within 4 weeks at the dose level prior to discontinuation of therapy
    • Monitor BCR-ABL transcript levels monthly until previous major molecular response or MR 4.0 is re-established and q12Weeks thereafter

Coadministration with strong CYP3A4 inhibitors

  • Avoid if possible; for patients who cannot avoid use of strong CYP3A4 inhibitors, monitor closely for QT prolongation
  • If patients must coadminister a strong CY3A4 inhibitor, reduce dose to 300 mg/day in patients with resistant or intolerant Ph+ CML or to 200 mg/day with newly diagnosed Ph+ CML-CP
  • However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inhibitors

Coadministration with strong CYP3A4 inducers

  • Avoid coadministration
  • Based on nonlinear pharmacokinetic profile of nilotinib, increasing the dose is unlikely to compensate for loss of nilotinib systemic exposure

Dosage Forms & Strengths

capsule

  • 50mg
  • 150mg
  • 200mg
more...

Chronic Myeloid Leukemia

Indicated for initial treatment of newly diagnosed Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML) in children and adolescents aged ≥1 year

Also, indicated for children and adolescents aged ≥1 year with Ph+ CP-CML resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy

230 mg/m² PO BID, round to the nearest 50 mg dose; not to exceed 400 mg/dose

Continue treatment until disease progression or unacceptable toxicity occurs

Dosage Modifications

Neutropenia and thrombocytopenia

  • ANC <1 x 10^9/L and/or platelets <50x 10^9/L
    • Stop nilotinib and monitor blood counts
    • Resume within 2 weeks to original dose if ANC >1.5 x 10^9/L and/or platelets >75 x 10^9/L
    • If ANC remains low for >2 weeks: Reduce dose to 230 mg/m² qDay
    • If event occurs after dose reduction, consider discontinuing treatment

QT Prolongation (QTc >480 msec)

  • Withhold drug and analyze serum potassium and magnesium; if below lower limit of normal, correct with supplements to within normal limits
  • Review concomitant medications for additive effects or interactions that increase nilotinib systemic exposure
  • Resume within 2 weeks at prior dose if QTc returns to <450 msec and to within 20 msec of baseline
  • If QTc is between 450-480 msec after 2 weeks, reduce nilotinib dose to 230 mg/m² qDay
  • Discontinue if QTc returns to >480 msec despite dose reduction
  • Repeat ECG ~7 days after any dose adjustment

Moderate or severe non-hematologic toxicity

  • Interrupt nilotinib until toxicity has resolved
  • Resume treatment at 230 mg/m² qDay if previous dose was 230 mg/m² BID; discontinue treatment if prior dose was 230 mg/m² qDay
  • If clinically appropriate, consider re-escalation of the dose to 230 mg/m² BID

Elevated serum lipase or amylase ≥Grade 3

  • Interrupt nilotinib until the event returns to ≤Grade 1
  • Resume treatment at 230 mg/m² qDay if prior dose was 230 mg/m² BID; discontinue treatment if prior dose was 230 mg/m² qDay

Elevated bilirubin or AST/ALT ≥Grade 3

  • Interrupt nilotinib until the event returns to ≤Grade 1
  • Resume treatment at 230 mg/m² qDay if prior dose was 230 mg/m² BID; discontinue treatment if prior dose was 230 mg/m² qDay, and recovery to ≤Grade 1 takes >28 days

Consider discontinuation of treatment after a sustained molecular response

  • Monitor BCR-ABL transcript levels and complete blood count (CBC) with differential in patients who have discontinued therapy monthly for 1 year, then q6Weeks for the second year, and q12Weeks thereafter
  • Newly diagnosed Ph+ CML-CP
    • Treatment with nilotinib for at least 3 years
    • Maintain a molecular response of at least MR4.0 (corresponding to = BCR-ABL/ABL ≤0.01% IS) for 1 year prior to discontinuation of therapy
    • Achieved an MR4.5 for the last assessment taken immediately prior to discontinuation of therapy
    • Been confirmed to express the typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2)
    • No history of accelerated phase or blast crisis
    • No history of prior attempts of treatment-free remission discontinuation that resulted in relapse
  • Patients with Ph+ CML-CP that are resistant or intolerant to treatment with imatinib
    • Treatment with nilotinib for at least 3 years
    • Previously treated with imatinib only prior to treatment with nilotinib
    • Achieved a molecular response of MR4.5 (corresponding to = BCR-ABL/ABL ≤ 0.0032% IS)
    • Sustained an MR4.5 for a minimum of 1 year immediately prior to discontinuation of therapy
    • Been confirmed to express the typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2)
    • No history of accelerated phase or blast crisis
    • No history of prior attempts of treatment-free remission discontinuation that resulted in relapse

Reinitiation of treatment in patients who lose molecular response after discontinuation of therapy

  • Newly diagnosed patients
    • Patients who lose MMR must reinitiate treatment within 4 weeks at the dose level prior to discontinuing treatment
    • Monitor BCR-ABL transcript levels monthly until major molecular response is re-established and q12Weeks thereafter
  • Resistant or intolerant Ph+ CML (chronic phase or accelerated phase)
    • Patients resistant or intolerant to prior treatment that included imatinib with confirmed loss of MR4.0 (2 consecutive measures separated by at least 4 weeks showing loss of MR4.0) or loss of MMR must reinitiate treatment within 4 weeks at the dose level prior to discontinuation of therapy
    • Monitor BCR-ABL transcript levels monthly until previous major molecular response or MR 4.0 is re-established and q12Weeks thereafter

Coadministration with strong CYP3A4 inhibitors

  • Avoid if possible; for patients who cannot avoid use of strong CYP3A4 inhibitors, monitor closely for QT prolongation
  • However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inhibitors

Coadministration with strong CYP3A4 inducers

  • Avoid coadministration
  • Based on nonlinear pharmacokinetic profile of nilotinib, increasing the dose is unlikely to compensate for loss of nilotinib systemic exposure
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Interactions

Interaction Checker

and nilotinib

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      Serious - Use Alternative

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            Adverse Effects

            >10%

            Rash (33%)

            Headache (31%)

            Nausea (31%)

            Pruritus (29%)

            Fatigue (28%)

            Pyrexia (24%)

            Diarrhea (22%)

            Constipation (21%)

            Vomiting (21%)

            Arthralgia (18%)

            Cough (17%)

            Extremity pain (16%)

            Asthenia (14%)

            Muscle spasms (14%)

            Myalgia (14%)

            Abdominal pain (13%)

            Bone pain (13%)

            Back pain (12%)

            Dyspnea (11%)

            Nasopharyngitis (11%)

            Peripheral edema (11%)

            1-10% (selected)

            Dizziness

            Insomnia

            Paresthesia

            QT interval prolongation

            HTN

            Palpitations

            QT interval prolongation

            Hyperglycemia

            Hyperkalemia

            Hypomagnesemia

            Neutropenia

            Pancytopenia

            <1%

            Peripheral arterial occlusive disease

            Tumor lysis syndrome

            Aortic valve sclerosis

            Abscess

            Amnesia

            Dehydration

            Postmarketing Reports

            Infections: Hepatitis B virus reactivation

            Sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis

            Thrombotic microangiopathy

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            Warnings

            Black Box Warnings

            QT prolongation

            • Prolongs QT interval; sudden death reported
            • Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome
            • Must correct hypokalemia or hypomagnesemia before initiating therapy
            • Monitor potassium and magnesium periodically
            • Avoid drugs known to prolong QT and strong CYP3A4 inhibitors
            • Reduced dose with hepatic impairment
            • Monitor QTc through electrocardiograms (ECGs) at baseline, 7 days after initiation, and periodically thereafter following any dose adjustments
            • Take on empty stomach; avoid food 2 hr before and 1 hr after taking dose

            Contraindications

            Long QT syndrome, hypokalemia, hypomagnesemia

            Cautions

            Grade 3/4 thrombocytopenia, neutropenia and anemia may occur (see Dosage Modifications)

            Sudden deaths reported 0.3% of patients with CML treated with nilotinib; ventricular repolarization abnormalities may have contributed to their occurrence; evaluate cardiovascular status and monitor/manage cardiovascular risk factors during therapy

            Prolongs QT interval; correct hypokalemia or hypomagnesemia before administration (see Black Box Warnings)

            Nilotinib can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia; correct hypokalemia or hypomagnesemia before administration; monitor periodically during therapy

            Cardiovascular events (eg, ischemic heart disease, peripheral arterial occlusive disease and ischemic cerebrovascular events) reported in patients with newly diagnosed Ph+ CML; cardiovascular status should be evaluated and cardiovascular risk factors monitored and managed during therapy

            Use caution in history of pancreatitis; monitor serum lipase monthly or as clinically indicated; in case lipase elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis

            Use caution in hepatic impairment; monitor hepatic function tests monthly or as clinically indicated; reduce dose and monitor QT interval

            May result in elevations in bilirubin, AST/ALT, and alkaline phosphatase; Grade 3-4 elevations of bilirubin, AST, and ALT were reported at higher frequency in pediatric than in adult patients; monitor hepatic function tests monthly or as clinically indicated

            Tumor lysis syndrome cases reported in nilotinib treated patients with resistant or intolerant CML; maintain adequate hydration and correct uric acid levels prior to initiating therapy

            Total gastrectomy may reduce nilotinib systemic exposure; perform more frequent follow-up of these patients; if necessary, consider dose increase or alternative therapy

            Hemorrhage from any site may occur; advise patients to report signs and symptoms of bleeding and medically manage as needed

            Monitor patients for signs of severe fluid retention (eg, unexpected rapid weight gain or swelling) and for symptoms of respiratory or cardiac compromise (eg, shortness of breath) during treatment; evaluate etiology and treat patients accordingly

            Women should be advised not to become pregnant while on therapy; may cause fetal harm (see Pregnancy)

            Adverse reactions associated with growth and development can occur in pediatric patients receiving BCR-ABL tyrosine kinase inhibitors

            Drug interaction overview

            • Food increases blood levels of nilotinib; avoid food 2 hr before and 1 hour after a dose
            • Coadministration with a strong CYP3A inhibitor increased nilotinib concentrations and toxicities (see Dosage Modifications)
            • Coadministration with a strong CYP3A inducer decreased nilotinib concentrations and toxicities (see Dosage Modifications)
            • Should treatment with any HMG-CoA reductase inhibitor (a lipid lowering agent) be needed to treat lipid elevations, evaluate potential for a drug-drug interaction before initiating
            • Contains lactose; avoid in galactose intolerance, lactase deficiency or glucose-galactose malabsorption
            • Drugs that affect gastric pH
              • Nilotinib has pH-dependent solubility, with decreased solubility at higher pH that may reduce its bioavailability
              • Coadministration with PPIs not recommended; PPIs decrease nilotinib AUC by ~34%
              • Administer H2 blockers ~10 hr before or 2 hr after nilotinib dose
              • Administer antacids 2 hr before or after nilotinib dose
            • Effects of nilotinib on drug metabolizing enzymes and drug transport systems
              • Nilotinib is a competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1 in vitro, potentially increasing the concentrations of drugs eliminated by these enzymes
              • Nilotinib may induce CYP2B6, CYP2C8 and CYP2C9, and decrease the concentrations of drugs which are eliminated by these enzymes
              • Nilotinib inhibits human P-glycoprotein (P-gp); drugs that inhibit P-gp, increased concentrations of nilotinib are likely, and caution should be exercised
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            Pregnancy & Lactation

            Pregnancy

            No available data in pregnant women to inform the drug-associated risk; in animal reproduction studies, administration of nilotinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, fetal effects, and fetal variations in rats and rabbits at maternal exposures (AUC) approximately 2 and 0.5 times, respectively, exposures in patients at recommended dose; advise pregnant women of potential risk to fetus

            Pregnancy test

            • Females of reproductive potential should have a pregnancy test prior to starting treatment

            Contraception

            • Based on animal studies, drug can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment with drug and for at least 14 days after the last dose

            Infertility

            • The risk of infertility in females or males of reproductive potential has not been studied in humans; in studies in rats and rabbits, the fertility in males and females was not affected

            Lactation

            No data are available regarding the presence of nilotinib or its metabolites in human milk or its effects on a breastfed child or on milk production

            However, nilotinib is present in the milk of lactating rats

            Owing to the potential for serious adverse reactions in a nursing child, advise lactating women not to breastfeed during treatment and for at least 14 days after the last dose

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Selectively binds with high affinity to ATP-binding site of BCR-ABL kinase inhibiting cell proliferation in cell lines and in primary Ph+ CML leukemia cells

            Active against imatinib-resistant mutant forms of Bcr-Abl

            Inhibits PDGFR and c-Kit kinase

            Absorption

            Peak plasma concentration: 1,540 ng/ml (300 mg BID)

            AUC: 13,337 ng·hr/ml (300 mg BID)

            Peak plasma time: 3 hr

            Distribution

            Protein Bound: 98%

            Blood-to-serum ratio: 0.68

            Metabolism

            Oxidation and hydroxylation by liver CYP3A4

            Enzymes Inhibited: CYP3A4, CYP2C8, CYP2C9, CYP2D6, UGT1A1

            Enzymes Induced CYP2B6, CYP2C8, CYP2C9

            Elimination

            Half-life: ~17 hr

            Clearance: ~29 L/hr

            Excretion: Feces 93%

            Pharmacogenomics

            Confirmed BCR-ABL transcripts

            • Tyrosine kinase inhibitors (TKIs) inhibit activity of BCR-ABL fusion protein, resulting in both hematologic response (ie, normal cell counts in the peripheral blood and normal bone marrow morphology), as well as cytogenetic response (ie, disappearance or reduction of the Philadelphia [Ph] chromosome)
            • NCCN clinical practice guidelines recommends TKIs in CML with confirmed BCR-ABL transcripts in bone marrow or evidence of translocation on cytogenetics

            UGT1A1 and increased bilirubin

            • Polymorphisms of UGT1A1 and its potential association with hyperbilirubinemia during nilotinib treatment have been studied
            • The (TA)7/(TA)7 genotype was associated with a statistically significant increase in the risk of hyperbilirubinemia relative to the (TA)6/(TA)6 and (TA)6/(TA)7 genotypes
            • However, the largest increases in bilirubin were observed in the (TA)7/(TA)7 genotype (UGT1A1*28) patients during nilotinib treatment

            Genetic testing laboratories

            • The following companies currently offer FISH and/or transcript quantification testing for BCR-ABL
            • Asuragen (http://www.asuragen.com/)
            • Dako (http://www.dakousa.com/)
            • Invitrogen (http://www.invitrogen.com/)
            • Ipsogen (http://www.ipsogen.com)
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            Administration

            Oral Administration

            Take twice daily at ~12-hr intervals (unless dosage modification required)

            Administer on empty stomach; do not consume food for at least 2 before the dose and for at least 1 hr after the dose is taken

            Swallow capsule whole with water

            If unable to swallow capsules, capsule contents may be dispersed in 1 teaspoon of applesauce; take mixture immediately (within 15 minutes) and do not be stored for future use

            Missed dose

            • If a dose is missed, take the next dose as scheduled
            • Do not double dose to make up for missed doses

            Storage

            Tablets: Store at room temperature between 68-77°F (20-25°C)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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